Vascular Flow Technologies has announced a new observational registry for Spiral Flow arteriovenous (AV) grafts in haemodialysis access that will be conducted by the Society for Vascular Surgery Patient Safety Organization (SVS PSO) as part of their ongoing Vascular Quality Initiative. The inititative is designed to improve vascular health care and provides an opportunity for individual providers, hospitals, and regional quality improvement groups to collect and analyse clinical data in an effort to improve patient care.
The SVS PSO evaluation of Spiral Laminar Flow will objectively measure the long-term safety, efficacy and cost effectiveness when used as the primary access for patients with end stage renal disease requiring routine haemodialysis. By restoring natural blood flow, and eliminating turbulence that can lead to neointimal hyperplasia, Spiral Flow AV grafts may result in higher patency rates and fewer interventions when compared to other marketed grafts.
The Spiral Flow Technology AV Access Registry (STAAR) will recruit up to 15 participating centres in the USA and enrol up to 75 patients with end stage renal disease who require synthetic graft placement for haemodialysis access. Patients will be followed for a period of up to 12 months following graft implantation.
The implanted Spiral Flow graft will be assessed for primary patency (intervention-free access survival), assisted primary patency (thrombosis-free access survival) and secondary patency (access survival until abandonment), as well as any complications that arise during that time.
Barbara Bunger, chief clinical officer for Vascular Flow Technologies, commented: “The STAAR post market registry will collect intraoperative and acute post-operative outcomes in addition to long term graft performance in real world clinical practice as patients undergo routine dialysis. We anticipate the resulting dataset to help confirm the hypothesis that Spiral Flow grafts have higher patency rates, and require fewer interventions than PTFE grafts resulting in lower costs to healthcare payers and healthcare providers.”
The SVS PSO Steering Committee will independently conduct and analyse the results of the STAAR under a prospectively designed protocol. An interim analysis will be performed when 25 subjects have completed 12 months of follow-up, and based on the projected patient recruitment rate, the full 12-month dataset will be available in 2017.